Prosthetic heart valve with upper skirt

• US 10,660,751 B2
• Filed: 08/06/2019
• Issued: 05/26/2020
• Est. Priority Date: 12/08/2009
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Cardiovalve Ltd.
• Inventors: Hacohen, Gil
• Primary Examiner(s): Ganesan, Suba
• Application Number:
  US16/532,945
• Publication Number:
  US 20200000580A1
• Time in Patent Office: 294 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

Apparatus for use at a native atrioventricular valve of a heart of a subject includes a prosthetic valve structure. The prosthetic valve structure comprises a valve ring, a leaflet frame, a plurality of prosthetic leaflets, and an upper skirt. The valve ring circumscribes a longitudinal axis of the prosthetic valve structure. The leaflet frame is disposed within the valve ring. The prosthetic leaflets are coupled to the leaflet frame, and are configured to facilitate upstream-to-downstream bloodflow longitudinally through the prosthetic valve structure. The upper skirt includes an annular skirt fabric, and an annular skirt frame coupled to the valve ring by the skirt fabric. The upper skirt extends radially outward and in an upstream direction from the valve ring. The upper skirt is configured to rest against an atrial portion of the native atrioventricular valve. Other embodiments are also described.

Claims

1. Apparatus for use at a native atrioventricular valve of a heart of a subject, the apparatus comprising a prosthetic valve structure that comprises:

a valve ring that circumscribes a longitudinal axis of the prosthetic valve structure;

a plurality of prong-shaped anchors distributed around the valve ring, each of the anchors projecting from the valve ring;

a leaflet frame, disposed within the valve ring;

a plurality of prosthetic leaflets, coupled to the leaflet frame, and configured to facilitate upstream-to-downstream bloodflow longitudinally through the prosthetic valve structure; and

an upper skirt,

(i) comprising;

an annular skirt fabric; and

an annular skirt frame coupled to the valve ring by the skirt fabric,

(ii) extending, radially outward and in an upstream direction, from the valve ring, and

(iii) configured to rest against an atrial portion of the native atrioventricular valve.

2. The apparatus according to claim 1, wherein an upstream portion of the leaflet frame is disposed within the valve ring.

3. The apparatus according to claim 2, wherein an upstream end of the leaflet frame is disposed within the valve ring.

4. The apparatus according to claim 2, wherein a downstream portion of the leaflet frame extends out of the valve ring.

5. The apparatus according to claim 4, wherein each of the leaflets is disposed within, and secured to, the downstream portion of the leaflet frame.

6. The apparatus according to claim 5, wherein each of the leaflets is also disposed within, and secured to, the upstream portion of the leaflet frame.

7. The apparatus according to claim 5, wherein:

the downstream portion of the leaflet frame comprises a plurality of posts, and

at each post of the plurality of posts, a part of a first leaflet of the plurality of leaflets converges with a part of a second leaflet of the plurality of leaflets,

the part of the first leaflet and the part of the second leaflet are secured to the post.

8. The apparatus according to claim 4, wherein all of the anchors are disposed entirely upstream of the downstream portion of the leaflet frame.

9. The apparatus according to claim 1, further comprising a fabric sleeve attached to the valve ring.

10. The apparatus according to claim 9, further comprising a leaflet frame fabric that is coupled to the leaflet frame, wherein the leaflet frame fabric is sutured to the fabric sleeve.

11. The apparatus according to claim 1, wherein all of the anchors are entirely disposed downstream of the upper skirt.

12. The apparatus according to claim 1, wherein each of the anchors projects from the valve ring radially outward and alongside the valve ring.

13. The apparatus according to claim 1, wherein each of the anchors projects from the valve ring, defining a space between the anchor and the valve ring.

14. The apparatus according to claim 1, wherein:

the valve ring comprises a plurality of metal segments joined at a respective plurality of joints, the joints facilitating (i) collapsing of the prosthetic valve structure into a collapsed state for transcatheter delivery to the heart, and (ii) expanding of the prosthetic valve structure into a deployed state within the heart, and

each of the anchors projects from a respective one of the plurality of joints.

15. The apparatus according to claim 14, wherein:

at each of the plurality of joints from which a respective anchor of the plurality of anchors projects, a first metal segment of the plurality of segments is joined to a second metal segment of the plurality of segments, and

the respective anchor is shorter than the first metal segment and is shorter than the second metal segment.

16. The apparatus according to claim 14, wherein, for each metal segment of the plurality of metal segments:

a first end of the metal segment is joined at a first joint from which a first anchor of the plurality of anchors projects,

a second end of the metal segment is joined at a second joint from which a second anchor of the plurality of anchors projects.

17. The apparatus according to claim 14, wherein at each of the plurality of joints from which a respective anchor of the plurality of anchors projects, the respective anchor projects from the respective joint and generally toward another anchor of the plurality of anchors.

18. The apparatus according to claim 14, wherein, in the collapsed state:

the metal segments are arranged in a circumferential ring that defines a series of peaks and troughs, thereby defining (i) joints that are disposed at the peaks as upper-joints, and (ii) joints that are disposed at the troughs as lower-joints,

at least one of the anchors projects from an upper-joint, and

at least one of the anchors projects from a lower-joint.

19. The apparatus according to claim 1, wherein the skirt frame comprises an elongate element that follows a closed wavy path that is (i) circumferentially around the longitudinal axis, and (ii) longitudinally separated from the valve ring.

20. The apparatus according to claim 19, wherein the elongate element is disposed radially outward from the valve ring.

21. The apparatus according to claim 19, wherein the prosthetic valve structure further comprises an additional elongate element that follows a closed wavy path that is (i) circumferentially around the longitudinal axis, and (ii) longitudinally separated from the valve ring.

22. The apparatus according to claim 19, wherein:

the elongate element is a first elongate element,

the closed wavy path is a first closed wavy path, and defines alternating first-path crests and first-path dips, the first-path crests being further from the longitudinal axis than the first-path dips,

the prosthetic valve structure further comprises a second elongate element that follows a second closed wavy path circumferentially around the longitudinal axis, the second closed wavy path defining alternating second-path crests and second-path dips, the second-path crests being further from the longitudinal axis than the second-path dips, and

the alternating of the second closed wavy path is out of phase with the alternating of the first closed wavy path.

23. The apparatus according to claim 19, wherein the wavy path has a wavelength, and wherein the prosthetic valve structure is collapsible into a collapsed state for transcatheter delivery to the heart, collapsing of the prosthetic valve structure into the collapsed state reducing the wavelength of the wavy path.

24. The apparatus according to claim 1, wherein the prosthetic valve structure is collapsible into a collapsed state for transcatheter delivery to the heart.

25. The apparatus according to claim 1, wherein the skirt frame comprises Nitinol.

26. Apparatus for use at a native atrioventricular valve of a heart of a subject, the apparatus comprising a prosthetic valve structure that comprises:

a valve ring that circumscribes a longitudinal axis of the prosthetic valve structure;

a leaflet frame, disposed within the valve ring;

a plurality of prosthetic leaflets, coupled to the leaflet frame, and configured to facilitate upstream-to-downstream bloodflow longitudinally through the prosthetic valve structure; and

an upper skirt,

(i) comprising;

an annular skirt fabric; and

an annular skirt frame coupled to the valve ring by the skirt fabric, and comprising an elongate element that follows a closed wavy path that is (i) circumferentially around the longitudinal axis, and (ii) longitudinally separated from the valve ring,

(ii) extending, radially outward and in an upstream direction, from the valve ring, and

(iii) configured to rest against an atrial portion of the native atrioventricular valve.

27. The apparatus according to claim 26, wherein an upstream portion of the leaflet frame is disposed within the valve ring.

28. The apparatus according to claim 27, wherein an upstream end of the leaflet frame is disposed within the valve ring.

29. The apparatus according to claim 27, wherein a downstream portion of the leaflet frame extends out of the valve ring.

30. The apparatus according to claim 29, wherein each of the leaflets is disposed within, and secured to, the downstream portion of the leaflet frame.

31. The apparatus according to claim 30, wherein each of the leaflets is also disposed within, and secured to, the upstream portion of the leaflet frame.

32. The apparatus according to claim 30, wherein:

the downstream portion of the leaflet frame comprises a plurality of posts,

at each post of the plurality of posts, a part of a first leaflet of the plurality of leaflets converges with a part of a second leaflet of the plurality of leaflets, and

the part of the first leaflet and the part of the second leaflet are secured to the post.

33. The apparatus according to claim 29, further comprising a plurality of prong-shaped anchors distributed around the valve ring, each of the anchors projecting from the valve ring, and all of the anchors being disposed entirely upstream of the downstream portion of the leaflet frame.

34. The apparatus according to claim 26, further comprising a fabric sleeve attached to the valve ring.

35. The apparatus according to claim 34, further comprising a leaflet frame fabric that is coupled to the leaflet frame, wherein the leaflet frame fabric is sutured to the fabric sleeve.

36. The apparatus according to claim 26, further comprising a plurality of prong-shaped anchors distributed around the valve ring, wherein each of the anchors projects from the valve ring, and all of the anchors are entirely disposed downstream of the upper skirt.

37. The apparatus according to claim 26, further comprising a plurality of prong-shaped anchors distributed around the valve ring, wherein each of the anchors projects from the valve ring radially outward and alongside the valve ring.

38. The apparatus according to claim 26, further comprising a plurality of prong-shaped anchors distributed around the valve ring, wherein each of the anchors projects from the valve ring, defining a space between the anchor and the valve ring.

39. The apparatus according to claim 26, further comprising a plurality of prong-shaped anchors distributed around the valve ring, wherein:

the valve ring comprises a plurality of metal segments joined at a respective plurality of joints, the joints facilitating (i) collapsing of the prosthetic valve structure into a collapsed state for transcatheter delivery to the heart, and (ii) expanding of the prosthetic valve structure into a deployed state within the heart, and

each of the anchors projects from a respective one of the plurality of joints.

40. The apparatus according to claim 39, wherein:

at each of the plurality of joints from which a respective anchor of the plurality of anchors projects, a first metal segment of the plurality of segments is joined to a second metal segment of the plurality of segments, and

the respective anchor is shorter than the first metal segment and is shorter than the second metal segment.

41. The apparatus according to claim 39, wherein, for each metal segment of the plurality of metal segments:

a first end of the metal segment is joined at a first joint from which a first anchor of the plurality of anchors projects, and

a second end of the metal segment is joined at a second joint from which a second anchor of the plurality of anchors projects.

42. The apparatus according to claim 39, wherein at each of the plurality of joints from which a respective anchor of the plurality of anchors projects, the respective anchor projects from the respective joint and generally toward another anchor of the plurality of anchors.

43. The apparatus according to claim 39, wherein, in the collapsed state:

the metal segments are arranged in a circumferential ring that defines a series of peaks and troughs, thereby defining (i) joints that are disposed at the peaks as upper-joints, and (ii) joints that are disposed at the troughs as lower-joints,

at least one of the anchors projects from an upper-joint, and

at least one of the anchors projects from a lower-joint.

44. The apparatus according to claim 26, wherein the elongate element is disposed radially outward from the valve ring.

45. The apparatus according to claim 26, wherein the prosthetic valve structure further comprises an additional elongate element that follows a closed wavy path that is (i) circumferentially around the longitudinal axis, and (ii) longitudinally separated from the valve ring.

46. The apparatus according to claim 26, wherein:

the elongate element is a first elongate element,

the closed wavy path is a first closed wavy path, and defines alternating first-path crests and first-path dips, the first-path crests being further from the longitudinal axis than the first-path dips,

the prosthetic valve structure further comprises a second elongate element that follows a second closed wavy path circumferentially around the longitudinal axis, the second closed wavy path defining alternating second-path crests and second-path dips, the second-path crests being further from the longitudinal axis than the second-path dips, and

the alternating of the second closed wavy path is out of phase with the alternating of the first closed wavy path.

47. The apparatus according to claim 26, wherein the wavy path has a wavelength, and wherein the prosthetic valve structure is collapsible into a collapsed state for transcatheter delivery to the heart, collapsing of the prosthetic valve structure into the collapsed state reducing the wavelength of the wavy path.

48. The apparatus according to claim 26, wherein the prosthetic valve structure is collapsible into a collapsed state for transcatheter delivery to the heart.

49. The apparatus according to claim 26, wherein the skirt frame comprises Nitinol.